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Tioguanine 40 Mg Tablets

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aspen


7202666-6764


Package Leaflet: Information for the User

Tioguanine 40 mg tablets

tioguanine

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions about your illness or your medicine, ask your doctor, nurse or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet:

1.    What Tioguanine is and what it is used for

2.    Before you take Tioguanine

3.    How to take Tioguanine

4.    Possible side effects

5.    How to store Tioguanine

6.    Further information


1 What Tioguanine is and what it is used for


Tioguanine tablets contain a medicine called tioguanine. This belongs to a group of medicines called cytotoxics (also called chemotherapy). Tioguanine is used for certain blood problems and cancers of the blood. It works by reducing the number of new blood cells your body makes.

Tioguanine is used for acute (fast-growing) leukaemias, especially:

Acute myelogenous leukaemia (also called acute myeloid leukaemia or AML)    - a fast-growing disease that increases the number of white blood cells produced by the bone marrow. This can cause infections and bleeding.

   Acute lymphoblastic leukaemia (also called acute lymphocytic leukaemia or ALL) - a fast-growing disease which increases the number of immature white blood cells. These immature white blood cells are unable to grow and function properly and therefore cannot fight infections and may cause bleeding.

   Chronic granulocytic leukaemia (also called chronic myeloid leukaemia) - a disease that increases the number of white blood cells. This can cause infections and bleeding.

Ask your doctor if you would like more explanation about these diseases.


2 Before you take Tioguanine


Take special care with Tioguanine

Before you take Tioguanine, tell your doctor or pharmacist if:

•    you have been taking this medicine for a long period of time. This may increase the chance of side effects, such as liver problems

•    you have a condition where your body produces too little of something called TPMT or 'thiopurine methyltransferase'

•    you have 'Lesch-Nyhan Syndrome'. This is a rare condition that runs in families caused by a lack of something called HPRT or 'hypoxanthine-guanine-phosphoribosyltransferase.

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before taking Tioguanine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

In particular tell your doctor or pharmacist if you are taking any of the following:

•    olsalzine or mesalazine - used for a bowel problem called ulcerative colitis

•    sulfasalazine - used for rheumatoid arthritis or ulcerative colitis.

Having vaccines while you are taking Tioguanine

If you are going to have a vaccination speak to your doctor or nurse before you have it. This is because some vaccines (like polio, measles, mumps and rubella) may give you an infection if you have them whilst you are taking Tioguanine.

Pregnancy and breast-feeding

Do not take Tioguanine if you are planning to have a baby. This applies to both men and women. Tioguanine may harm your sperm or eggs. Reliable contraceptive precautions must be taken to avoid pregnancy whilst you or your partner are taking these tablets. Ask your doctor for advice.

If you are already pregnant, it is important to talk to your doctor before taking Tioguanine. Do not breast-feed while taking Tioguanine. Ask your doctor or midwife for advice.


3 How to take Tioguanine


Tioguanine should only be given to you by a specialist doctor who is experienced in treating blood problems.

Always take Tioguanine exactly as your doctor has told you. It is important to take your medicine at the right times. The label on your pack will tell you how many tablets to take and how often to take them. If the label doesn't say or if you are not sure, ask your doctor, nurse or pharmacist.

• Swallow your tablets whole with a glass of water.


•    If you need to break your tablet in half, do not inhale any tablet powder. Wash your hands afterwards.

•    When you take Tioguanine your doctor will take regular blood tests. This is to check the number and type of cells in your blood and to ensure your liver is working correctly. Your doctor may sometimes change your dose as a result.

The dose of Tioguanine you are given will be worked out by your doctor based on:

•    your body size (surface area)

•    the results of your blood test

•    the disease being treated.

•    The usual dose is between 100 and 200 mg/m2 body surface area per day. If you have a problem with your kidneys or liver you may be given a lower dose of Tioguanine.

If you take more Tioguanine than you should

If you take more Tioguanine than you should, tell your doctor immediately or go to a

hospital straight away. Take the medicine pack with you.

If you forget to take Tioguanine

Tell your doctor. Do not take a double dose to make up for a forgotten dose.


4 Possible side effects


Like all medicines, Tioguanine can cause side effects, although not everybody gets them.

If you get any of the following, talk to your specialist doctor or go to hospital straight away:

•    any signs of fever or infection (sore throat, sore mouth or urinary problems)

•    any unexpected bruising or bleeding, as this could mean that too few blood cells of a particular type are being produced

•    if you suddenly feel unwell (even with a normal temperature)

•    any yellowing of the whites of the eyes or skin (jaundice).

Talk to your doctor if you have any of the following side effects which may also happen with this medicine:

Very common (affects more than 1 in 10 people)

•    a drop in the number of your blood cells

•    jaundice and severe liver damage - with long term use or high doses of Tioguanine. Common (affects less than 1 in 10 people)

•    liver damage which can cause jaundice or an enlarged liver (a swelling below your ribcage) - with short term use of Tioguanine.

•    feeling or being sick (nausea or vomiting), diarrhoea and mouth ulcers.

Rare (affects less than 1 in 1,000 people)

•    a problem with your bowels, called intestinal necrosis, which can cause severe stomach ache, being sick, diarrhoea and fever

•    severe liver damage when used with other chemotherapy drugs, oral contraceptives and alcohol.


5 How to store Tioguanine


•    Keep out of the reach and sight of children.

•    Do not use Tioguanine after the expiry date which is stated on the pack after 'Exp'.

•    Do not store your Tioguanine tablets above 25°C.

•    If your doctor tells you to stop taking the tablets, it is important to return any which are left over to your pharmacist, who will destroy them according to disposal of dangerous substance guidelines. Only keep the tablets if your doctor tells you to.


6 Further information


What Tioguanine contains

The active ingredient is tioguanine. Each Tioguanine tablet contains 40 mg of tioguanine.

The other ingredients are anhydrous lactose, starch (potato), acacia, stearic acid, magnesium stearate and purified water.

What Tioguanine looks like and contents of the pack

Tioguanine tablets are white to off-white tablet, round, biconvex scored and imprinting 'T40' on upper side, without score and debossing on lower side. Your Tioguanine tablets are in bottles of 25 tablets.


Marketing Authorisation Holder and Manufacturer

Aspen Pharma Trading Limited 3016 Lake Drive,

Citywest Business Campus,

Dublin 24, Ireland

Service-Tel: 0800 008 7392 (+ 44 1748 828 391)


Manufacturer:

EXCELLA GmbH, 90537 Feucht, Germany


Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name    Tioguanine 40mg tablets

Reference number    PL 39699/0045

This is a service provided by the Royal National Institute of Blind People.

Leaflet Date: August 2014



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